FDA’s new report regarding root causes and potential solutions to drug shortages

Oct. 30, 2019

The U.S. Food & Drug Administration (FDA) has issued a report, Shortages: Root Causes and Potential Solutions, which examines the underlying factors responsible for drug shortages and recommends enduring solutions.

The inter-agency Drug Shortage Task Force, which was led by FDA, oversaw the analysis of drug shortage data and development of recommendations in response to a request from 31 U.S. senators and 104 U.S. congressional representatives in June 2018. The report relies on information from stakeholders, published research and economic analysis of market conditions affecting drug shortages.

The report identifies three root causes for drug shortages:

·   Lack of incentives for manufacturers to produce less profitable drugs;

·   The market does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues; and

·   Logistical and regulatory challenges make it difficult for the market to recover from a disruption.

The report also recommends enduring solutions to address drug shortages. These solutions include:

·   Creating a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to shortages;

·   Developing a rating system to incentivize drug manufacturers to invest in quality management maturity for their facilities; and

·   Promoting sustainable private sector contracts (e.g., with payers, purchasers and group purchasing organizations) to make sure there is a reliable supply of medically important drugs. 

In addition, the report describes legislative proposals in the President’s FY2020 Budget and planned FDA initiatives to prevent and mitigate shortages that look at improved data sharing, risk management, lengthened expiration dates for drugs and internationally harmonized guidelines for a pharmaceutical quality system.

FDA has the release.